Pulmicort turbuhaler powder for inhalation 100mcg dose 200dose
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Active ingredients
Budesonide
Release form
Powder
Composition
1 dose of powder for inhalation contains: Active substance: budesonid 100 mcg.
Pharmacological effect
Glucocorticosteroid for topical use. Budesonide is a glucocorticosteroid with a strong local anti-inflammatory effect. The exact mechanism of action of glucocorticosteroids in the treatment of bronchial asthma is not completely clear. Anti-inflammatory effects, such as inhibiting the release of inflammatory mediators and the cytokine-mediated immune response, are perhaps the most important. The affinity of budesonide for glucocorticosteroid receptors is 15 times higher than that of prednisone. The anti-inflammatory effect of budesonide is mediated by a decrease in the degree of airway obstruction during the early and late allergic response. Budesonide reduces the reactivity of the respiratory tract in response to the inhalation of histamine and methacholine. The earlier the diagnosis of bronchial asthma persists, treatment with budesonide is started, the greater the improvement in lung function is to be expected. . At recommended doses, the drug has a significantly smaller effect on adrenal function than prednisone at a dose of 10 mg as was shown in ACTH tests. The use of budesonide at a dose of up to 400 mcg / day in children over 3 years of age did not lead to systemic effects. Biochemical signs of the systemic effect of the drug can occur when taking the drug in a dose of 400 to 800 mg / day. When a dose of 800 mcg / day is exceeded, the systemic effects of the drug are often encountered. The use of glucocorticosteroids for the treatment of bronchial asthma can cause dysplasia. normative indicators for adults. Therapy with inhaled budesonide 1 or 2 times / day showed efficacy in the prevention of asthma of physical effort.
Pharmacokinetics
AbsorptionIngalable budesonide is rapidly absorbed. After inhalation using the turbuhaler, about 25-35% of the measured dose is delivered to the lungs.The maximum plasma concentration is reached 30 minutes after inhalation. Systemic bioavailability of the drug is about 38% of the dose taken. Metabolism and distribution Binding to plasma proteins averages 90%. The volume of distribution of budesonide is approximately 3 l / kg. After absorption, budesonide undergoes intensive (more than 90%) biotransformation in the liver with the formation of metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites of 6β-hydroxybudonesonide and 16α-hydroxyprednisolone is less than 1% of glucocorticosteroid activity of budesonide. ExcretionBudesonide is metabolized mainly with the participation of the CYP 3A4 enzyme. Metabolites are excreted unchanged in the urine or in conjugated form. A small amount of unchanged budesonide is excreted in the urine. Budesonide has a high system clearance (about 1.2 l / min). The pharmacokinetic of budesonide is proportional to the size of the administered dose of the drug. The pharmacokinetics of budesonide in children and patients with impaired renal function is unknown. Patients with liver disease may increase the time spent by budesonide in the body.
Indications
- bronchial asthma requiring maintenance therapy with glucocorticosteroids to control the inflammatory process. - chronic obstructive pulmonary disease (COPD).
Contraindications
- children's age up to 6 years; - hypersensitivity to budesonide. Caution should be exercised when treating patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory organs with inhaled glucocorticosteroids.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Pregnancy: While receiving budesonide in pregnant women, there was no increase in the risk of developmental abnormalities in the fetus. Nevertheless, the risk of their development cannot be completely ruled out. Therefore, during pregnancy, due to the potential for worsening asthma, the minimum effective dose of budesonide should be used. Results of studies on animals have shown that glucocorticosteroids can cause abnormalities in fetal development,however, these data should not be extrapolated to people receiving glucocorticosteroids at recommended doses. Lactation: There is no data on the availability of budesonide in breast milk. When prescribing the drug, consider the ratio of the intended benefits to the mother and the potential risk to the baby.
Dosage and administration
The dose of Pulmicort Turbuhalera is selected individually. Recommended doses of the drug in the event of initiation of inhaled glucocorticosteroid therapy during severe exacerbations of asthma, as well as on the background of dose reduction or discontinuation of oral GCS are as follows: Children over 6 years old: 100-800 mcg / day (total daily allowance of the drug at home can be divided into 2-4 inhalations). In that case, if the recommended dose does not exceed 400 mg / day, the entire dose of the drug can be taken at once (once). In children, the transition to a single dose of the drug should be carried out under the supervision of a pediatrician. Adults: the usual dose is 200-800 mg / day (the total daily dose of the drug can be divided into 2-4 inhalations). For the treatment of severe exacerbation of asthma, the daily dose may be increased to 1600 mcg. If the recommended dose does not exceed 400 mcg / day, the entire dose of the drug can be taken at once (once). When selecting a maintenance dose, you should strive to prescribe the minimum effective dose. The start time of the therapeutic effect after inhalation of one dose of the drug is several hours. The maximum therapeutic effect is achieved within 1-2 weeks after treatment. Pulmicort Turbuhaler has a prophylactic effect on the course of asthma and does not affect the acute manifestations of the disease. The best efficacy of budesonide when using the Turbuhaler is demonstrated compared with a similar dose of budesonide in the form of a metered-dose aerosol. If a patient is in a stable condition to transfer from Pulmicort in aerosol form to Pulmicort Turbuhaler, the possibility of reducing the daily dose of budesonide should be considered. To enhance the therapeutic effect, an increase in the daily dose of Pulmicort Turbuhaler instead of a combination of the drug with oral glucocorticosteroids can be recommended due to the lower risk of developing systems effects.Patients receiving oral glucocorticosteroids: Canceling the administration of oral glucocorticosteroids is necessary Dimo spend on the background of a stable patient's health.Within 10 days, it is recommended to take a high dose of Pulmicort while taking oral glucocorticosteroids at the selected dose. In the future, the dose of oral glucocorticosteroids should be gradually reduced (for example, 2.5 mg of prednisolone or its analogues) to the lowest possible level. In many cases, it is possible to completely refuse to take oral glucocorticosteroids. There is no data on the use of budesonide in patients with renal insufficiency or impaired liver function. Taking into account the removal of budesonide due to biotransformation in the liver, we can expect an increase in the duration of action of the drug in patients with severe cirrhosis of the liver. Carefully read the instructions for using Pulmicort Turbuhalera. To be sure that the optimal dose of the drug has entered the lungs, take a deep and strong breath s mouthpiece Turbuhalera.Ni under any circumstances, exhale through mundshtuk.Posle required dose inhalation, rinse your mouth with water to minimize the risk of fungal infections of the oropharynx.
Side effects
Up to 10% of patients taking the drug may experience the following side effects: Frequent (> 1/100) Airways: Oropharyngeal candidiasis, pharynx irritation, cough, hoarseness Rare (<1/1000) General: Angioedema Skin: Urticaria, rash, contact dermatitis Respiratory tract: Bronchospasm Neuropsychiatric symptoms, such as nervousness, irritability, depression, behavioral disturbances, can also be observed. Taking into account the risk of developing oropharyngeal candidiasis, the patient must thoroughly rinse his mouth with water after each inhalation of the drug. In rare cases, symptoms may occur caused by the systemic action of glucocorticosteroids, including adrenal hypofunction. In rare cases, bruising was observed on the skin.
Overdose
In case of an overdose of Pulmicort Turbuhaler in doses significantly exceeding the recommended, clinical manifestations do not occur.With prolonged use of the drug in doses significantly higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercorticism and suppression of adrenal function.
Interaction with other drugs
No interaction between budesonide and other drugs used in the treatment of bronchial asthma was observed. Ketoconazole (200 mg / day) increases the plasma concentration of oral budesonide (3 mg / day) and an average of 6 times when taken together. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter and the blood plasma increased on average 3 times. There is no information about such an interaction when taking an inhaled budesonide, however, it is assumed that in this case, too, an increase in plasma concentration of budesonnd should be expected. You should not prescribe these drugs at the same time due to lack of data. If necessary, the joint appointment of ketoconazole and budesovnd the time between taking the drugs should be increased to the maximum possible. You should also consider reducing the dose of budesonide. Other potential inhibitors of the CYP 3A4 enzyme (for example, itraconazole) also cause a significant increase in plasma concentrations of budesonide.
special instructions
To minimize the risk of fungal infections of the oropharynx, instruct the patient to rinse the mouth thoroughly with water after each inhalation of the drug. Avoid co-administration of budesonide with ketoconazole, itraconazole or other potential CYP 3A4 inhibitors. In the event that budesonide and ketocanazole or intracladmin or other potential inhibitors of CYP 3A4 have been prescribed, the time between taking the drugs should be increased to the maximum possible. Pulmicort Also, special attention should be paid to patients who took high doses of glucocorticosteroids, or who received the highest possible doses of inhaled glucocorticosteroids for a long time.In stressful situations, these patients may show signs and symptoms of adrenal insufficiency. In case of stress or in cases of surgical intervention, additional therapy with systemic glucocorticosteroids is recommended. Special attention should be paid to patients who are transferred from systemic to inhaled glucocorticosteroids (Pulmicort Turbuhaler) or in case that a violation of the pituitary-adrenal function can be expected. In such patients, it is necessary to carefully reduce the dose of systemic corticosteroids and control the hormonal function of the adrenal glands. Patients may also be required to take oral glucocorticosteroids during stressful situations, such as trauma, surgery, etc. When switching from oral glucocorticosteroids to Pulmicort Turbuhaler, patients may experience previously observed symptoms, such as muscle pain or joint pain. In such cases, a temporary increase in the dose of oral glucocorticosteroids may be necessary. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may be observed, indicating systemic deficiency of the GCS. Replacing oral glucocorticosteroids for inhalation sometimes leads to manifestation of concomitant allergies, such as rhinitis and eczema that were previously stopped by systemic drugs. In children and adolescents receiving treatment with glucocorticosteroids (regardless of the delivery method) for an extended period, it is recommended to regularly monitor growth indicators. Patients should be instructed about the need to contact your doctor in case of reduced effectiveness of therapy with short-acting bronchodilators, as an independent increase in the frequency of use of the drug may lead to a delay in the appointment of adequate treatment. In case of a sudden deterioration of the condition, it is necessary to consider the possibility of a course of treatment with oral glucocorticosteroids. Impact on the ability to drive vehicles and control mechanisms. The Pulmicort Turbuhaler does not affect the ability to drive a car or other mechanisms.